Postoperative Exercise Training and Colorectal Cancer Liver Metastasis

NCT05579340 | Active Not Recruiting

• 1 other identifier: POET-mCRC
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 25% of colorectal cancer (CRC) patients are diagnosed with liver metastases, which is the most common site of metastasis, already during the primary tumor diagnosis. Another 30% of the patients will develop liver metastases at a later stage. Even though patient can be treated by surgical resection of the metastatic tumor, 50-75% of the patients experience a relapse in less than two years. Due to the high probability of relapse, mCRC patients undergo multiple rounds of surgery and adjuvant treatment (chemotherapy/radiotherapy) which results in substantial physical de-conditioning. Physical activity has been shown to increase the progression-free survival rates in mCRC patients, when applied post-diagnosis. Increased cardiorespiratory fitness (VO2peak) at the time of diagnosis among CRC individuals has been associated with lower risk of all-cause mortality. Although data on the effect of chronic exercise on VO2peak have emerged, thus far, there is no randomized clinical trial that has investigated the effects of exercise training in mCRC patients early after surgical treatment with curative intent. Therefore, this project aims to address the beneficial effect of structured exercise training primarily on VO2peak and tumor recurrence in mCRC patients immediately after surgical treatment and while they are undergoing adjuvant chemotherapy/radiotherapy. A total of 66 participants will be recruited from the Department of Surgery and Transplantation, Rigshospitalet and randomly allocated to a standard care control group (n=22), standard care plus 150 min/week exercise training (n=22) or standard care plus 300 min/week exercise training (n=22). Participants will undergo exercise training for 6 months, starting immediately after surgery, and they will be followed for additional 6 months. Tumor recurrence will be evaluated up to 3 years after training initiation.

Conditions

Cancer Metastatic to Liver; Cancer Colorectal

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen consumption (VO2peak)

  Changes in VO2peak assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer

  Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

Secondary Outcomes (62)

• 3-years recurrence-free survival

  Randomization to 3 years after randomization

• 3-years overall survival

  Randomization to 3 years after randomization

• Changes in Aerobic Capacity: Ventilatory threshold

  Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

• Changes in Aerobic Capacity: Peak power output

  Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

• Changes in Muscle strength: Hand grip strength

  Baseline, 3-, 6-, 9- and 12 months after exercise training initiation

Study Arms (3)

Usual care

NO INTERVENTION

Ex1

EXPERIMENTAL

Low exercise volume (150 min/week)

Other: Exercise

Ex2

EXPERIMENTAL

High exercise volume (300 min/week)

Other: Exercise

Interventions

Exercise OTHER

6 months of combined aerobic and resistance exercise

Ex1; Ex2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colorectal cancer patients diagnosed with liver metastasis and scheduled for liver metastasis surgical resection

You may not qualify if:

• Age \<18
• Pregnancy
• Physical or mental disabilities that prohibit execution of test or training procedures
• Inability to understand the Danish language.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet (CFAS)

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Casper Simonsen, PhD

  Group Leader

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 13, 2022
• Study Start: April 18, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)